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FDA 510(k)

Nasal Pancreatic Drainage Set

K-Number: K171623 · 2017-07-31

ApplicantCook Ireland, Ltd.
Decision Date2017-07-31
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Nasal Pancreatic Drainage Set is a medical device manufactured by Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2017-07-31 under approval number K171623. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nasal Pancreatic Drainage Set?

Nasal Pancreatic Drainage Set is a medical device that received FDA 510(k) clearance on 2017-07-31. It is manufactured by Cook Ireland, Ltd.. The 510(k) number is K171623.

When was Nasal Pancreatic Drainage Set approved by the FDA?

Nasal Pancreatic Drainage Set received FDA 510(k) clearance on 2017-07-31, under approval number K171623.

What company makes Nasal Pancreatic Drainage Set?

Nasal Pancreatic Drainage Set is manufactured by Cook Ireland, Ltd..

What is the FDA product code for Nasal Pancreatic Drainage Set?

The FDA product code for Nasal Pancreatic Drainage Set is FGE.

Related Clinical Trials

NCT07606430 Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction NOT_YET_RECRUITING NCT07432607 High-Flow Nasal Oxygen vs. Face Mask During Sedoanalgesia in Non-Intubated Thoracoscopic Pericardial Window Surgery RECRUITING

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Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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